Simultaneous Quantitative Estimation of Lisinopril and Hydrochlorothiazide Residues Using HPLC for Cleaning Validation

Abstract

A new, rapid and selective, HPLC method for simultaneous quantitative estimation of lisinopril and hydrochlorothiazide residues and sampling procedures from pharmaceutical manufacturing equipment surfaces were developed and validated. The sampling procedures have a good recovery (>80%). The limit of quantitation of the HPLC method - 0.155 µg/mL and 0.025 µg/mL for lisinopril and hydrochlorothiazide, respectively.

Keywords

• lisinopril
• hydrochlorthiazide
• swab sampling
• rinse sampling
• hplc
• validation